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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P100040 S012
Study Name OSB Lead-Comprehensive/Linked-Registry Based Surv.
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Study involve follow-up of premarket cohort (Y/N) No
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description The purpose of this surveillance project, using the Society for Vascular Surgery Vascular Quality Initiative   show the rest ...
Study Population Description Two surveillance arms:

a. Five (5)-year cohort: Data will be captured on a minimum of 200   show the rest ...
Sample Size Five (5)-year cohort:

The Professional Societies estimated the 5-year incidence of dissection- related mortality as 10%   show the rest ...
Data Collection Case report forms within the VQI Registry.

Long term follow-up may be enhanced with claims data   show the rest ...
Followup Visits and Length of Followup up to five years

OSB Lead-Comprehensive/Linked-Registry Based Surv. Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
FDA 6 month report 07/23/2014 07/21/2014 On Time
FDA one year report 01/22/2015 01/14/2015 On Time
FDA 18 month report 07/23/2015 07/17/2015 On Time
FDA 2 year report 01/22/2016 01/13/2016 On Time
FDA 3 year report 01/21/2017    
FDA 4 year report 01/21/2018    
FDA 5 year report 01/21/2019    

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